Ovarian NeoplasmsPhase 1NCT02711345

A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.

A Phase 1 study testing LTT462 in people with Ovarian Neoplasms and Non-Small-Cell Lung Carcinoma, run by Novartis Pharmaceuticals at 7 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma, Melanoma
What is being tested?: LTT462
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 7 sitesin 6 countries
Study dates: 15 Apr 2016to 21 Nov 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patient (male or female) ≥12 years of age
ECOG (Eastern Cooperative Oncology Group) performance status ≤1
Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
Patients must be willing and able to undergo study required biopsies.
Presence of at least one measurable lesion according to RECIST v1.1.
Documented MAPK pathway alteration

Who cannot join

Prior treatment with ERK inhibitors.
History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
Patients with malignant disease other than that being treated in the study.
Clinically significant cardiac disease.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

7 sites in 6 countries.

Country

City, postcode or hospital

7 sites in 6 countries

United States2 sites

Novartis Investigative Site
Houston, Texas, 77030-4009
Novartis Investigative Site
New York, New York, 10065

Other trials in United States

Germany1 site

Novartis Investigative Site
Essen, 45147

Other trials in Germany

Japan1 site

Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045

Other trials in Japan

Singapore1 site

Novartis Investigative Site
Singapore, 169610

Other trials in Singapore

Spain1 site

Novartis Investigative Site
Barcelona, Catalonia, 08035

Other trials in Spain

Switzerland1 site

Novartis Investigative Site
Bellinzona, 6500

Other trials in Switzerland

About this study

Official title: A Phase I Dose Finding Study of Oral LTT462 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations.

A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.

Conditions: Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma, Melanoma, Other Solid Tumors
Being tested: LTT462
Keywords: LTT462, ERK, MAPK, solid tumor
Medical subject headings: Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LTT462Drug
ERK Inhibitor

Study groups in NCT02711345
Study group	Role	What they receive
Escalation	Experimental	Not described Receives: Drug: LTT462
Expansion Group 1	Experimental	Not described Receives: Drug: LTT462
Expansion Group 2	Experimental	Not described Receives: Drug: LTT462
Expansion Group 3	Experimental	Not described Receives: Drug: LTT462
Expansion Group 4	Experimental	Not described Receives: Drug: LTT462

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse events is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. A SAE is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
Measured: Up to 2.8 years
Percentage of Participants With Dose Limiting Toxicities (DLTs)
Percentage of participants with dose limiting toxicity were reported.
Measured: Up to 2.8 years
Percentage of Participants With at Least One Dose Reduction
Percentage of participants with at least one dose reduction were reported.
Measured: Up to 2.8 years
Percentage of Participants With at Least One Dose Interruptions
Percentage of participants with at least dose interruptions were reported.
Measured: Up to 2.8 years
Dose Intensity Received by Participants
Dose intensity of LTT462 received by treatment group was reported.
Measured: Up to 2.8 years

Secondary outcomes (12)

Percentage of Participants With Overall Response Rate (ORR)
Percentage of participants with overall response rate were reported.
Measured: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
Percentage of Participants With Disease Control Rate (DCR)
Percentage of participants with disease control rate were reported.
Measured: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
Duration of Response (DOR)
DOR is defined as the time between the date of the first documented response (complete response [CR] or partial response [PR]) and the date of progression.
Measured: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
Progression Free Survival (PFS)
Median time for progression free survival was reported.
Measured: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
Overall Survival (OS) - Only for Dose Expansion Phase
Median time for overall survival, only for dose expansion phase was reported.
Measured: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
The Maximum (Peak) Observed Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Cmax) After Single Dose Administration of LTT462
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration expressed in mass x volume-1.
Measured: day 1, day 15
Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LTT462
AUClast is the area under the curve from time zero to the last measurable concentration sampling time calculated by mass * time *volume^-1
Measured: Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
The Time to Reach Maximum (Peak) Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Tmax) After Single Dose Administration of LTT462
Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Measured: day 1, day 15
Elimination Half-life (T1/2) of LTT462
T1/2 is the Elimination half-life.
Measured: Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
The Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of LTT462
AUCtau is the area under the curve calculated to the end of a dosing interval (tau) at steady-state calculated by formula amount *time * volume^-1
Measured: Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
Accumulation Ratio (Racc) of LTT462
Racc is the accumulation ratio calculated by AUCtau ratio Day 15 versus Day 1.
Measured: Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
Changes From Baseline in Relative Quantity (RQ) of Dual Specificity Phosphatase 6 (DUSP6) in Tumor Tissue and in Blood
Assessment of Pharmacodynamic (PD) effects of LTT462 in tumor, pre- and post- treatment tumor biopsies were examined for expression of DUSP6. For assessment of PD effects in blood, levels of DUSP6 were measured in blood samples.
Measured: Cycle 1 Days 1, 2, 3, 15 and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201621 Nov 2018

First posted17 Mar 2016 (estimated)
Study start15 Apr 2016
Primary completion21 Nov 2018
Study completion21 Nov 2018

Why it stopped: considering the limited clinical activity observed with LTT462, the decision was made to not open the dose expansion phase of the study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02711345
Sponsor's protocol ID: CLTT462X2101
Other IDs: 2015-003614-24, 2015
Status last verified: Aug 2019
First submitted: 16 Feb 2016
Last updated: 19 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ovarian Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Dose Finding Study of Oral LTT462 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations.
ClinicalTrials.gov ID: NCT02711345
Acronym / sponsor ID: CLTT462X2101
Conditions: Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma, Melanoma, Other Solid Tumors
Keywords: LTT462, ERK, MAPK, solid tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: considering the limited clinical activity observed with LTT462, the decision was made to not open the dose expansion phase of the study
Enrolment: 65 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 15 Apr 2016 (actual)
Primary completion: 21 Nov 2018 (actual)
Study completion: 21 Nov 2018 (actual)
First posted: 17 Mar 2016 (estimated)
Results: Posted 19 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Escalation	Experimental	Drug: LTT462
Expansion Group 1	Experimental	Drug: LTT462
Expansion Group 2	Experimental	Drug: LTT462
Expansion Group 3	Experimental	Drug: LTT462
Expansion Group 4	Experimental	Drug: LTT462

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Patient (male or female) ≥12 years of age
ECOG (Eastern Cooperative Oncology Group) performance status ≤1
Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
Patients must be willing and able to undergo study required biopsies.
Presence of at least one measurable lesion according to RECIST v1.1.

Key exclusion criteria (7 listed)

Prior treatment with ERK inhibitors.
History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
Patients with malignant disease other than that being treated in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LTT462ERK Inhibitor	Drug	Escalation, Expansion Group 1, Expansion Group 2, Expansion Group 3, Expansion Group 4

Primary outcome

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2.8 years
An adverse events is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. A SAE is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
Percentage of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 2.8 years
Percentage of participants with dose limiting toxicity were reported.
Percentage of Participants With at Least One Dose Reduction
Time frame: Up to 2.8 years
Percentage of participants with at least one dose reduction were reported.
Percentage of Participants With at Least One Dose Interruptions
Time frame: Up to 2.8 years
Percentage of participants with at least dose interruptions were reported.
Dose Intensity Received by Participants
Time frame: Up to 2.8 years
Dose intensity of LTT462 received by treatment group was reported.

12 secondary outcomes

Percentage of Participants With Overall Response Rate (ORR)
Time frame: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
Percentage of Participants With Disease Control Rate (DCR)
Time frame: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
Duration of Response (DOR)
Time frame: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
Progression Free Survival (PFS)
Time frame: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
Overall Survival (OS) - Only for Dose Expansion Phase
Time frame: Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
The Maximum (Peak) Observed Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Cmax) After Single Dose Administration of LTT462
Time frame: day 1, day 15
Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LTT462
Time frame: Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
The Time to Reach Maximum (Peak) Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Tmax) After Single Dose Administration of LTT462
Time frame: day 1, day 15
Elimination Half-life (T1/2) of LTT462
Time frame: Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
The Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of LTT462
Time frame: Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
Accumulation Ratio (Racc) of LTT462
Time frame: Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
Changes From Baseline in Relative Quantity (RQ) of Dual Specificity Phosphatase 6 (DUSP6) in Tumor Tissue and in Blood
Time frame: Cycle 1 Days 1, 2, 3, 15 and 16

Results and safety

Results posted to the registry on 19 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LTT462 45 mg QD	2	0
LTT462 100 mg QD	3	0
LTT462 150 mg QD	6	0
LTT462 200 mg QD	4	0
LTT462 300 mg QD	8	0
LTT462 400 mg QD	6	0
LTT462 450 mg QD	12	0
LTT462 600 mg QD	6	0
LTT462 150 mg BID	6	0
LTT462 200 mg BID	12	0

Primary outcome: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 2.8 years. Number. Unit: Percentage of participants

Measure	LTT462 45 mg QD n = 2	LTT462 100 mg QD n = 3	LTT462 150 mg QD n = 6	LTT462 200 mg QD n = 4	LTT462 300 mg QD n = 8	LTT462 400 mg QD n = 6	LTT462 450 mg QD n = 12	LTT462 600 mg QD n = 6	LTT462 150 mg BID n = 6	LTT462 200 mg BID n = 12
AEs	2	3	6	4	8	6	12	5	6	12
SAEs	1	0	3	1	5	1	8	4	3	5

Population analysed: The safety set included all participants who had received at least one dose of LTT462.

Primary outcome: Percentage of Participants With Dose Limiting Toxicities (DLTs)

Time frame: Up to 2.8 years. Number. Unit: Percentage of participants

Measure	LTT462 45 mg QD n = 2	LTT462 100 mg QD n = 3	LTT462 150 mg QD n = 6	LTT462 200 mg QD n = 4	LTT462 300 mg QD n = 7	LTT462 400 mg QD n = 4	LTT462 450 mg QD n = 7	LTT462 600 mg QD n = 3	LTT462 150 mg BID n = 4	LTT462 200 mg BID n = 9
Value	0	0	16.7	25.0	0	0	28.6	100	0	44.4

Population analysed: The dose determining set included all participants from the safety set enrolled in the escalation part of the study who, during the first 28 days of dosing, had received at least 75 percent of the planned daily doses of LTT462 and had had sufficient safety evaluations, or had experienced a DLT.

Primary outcome: Percentage of Participants With at Least One Dose Reduction

Time frame: Up to 2.8 years. Number. Unit: Percentage of participants

Measure	LTT462 45 mg QD n = 2	LTT462 100 mg QD n = 3	LTT462 150 mg QD n = 6	LTT462 200 mg QD n = 4	LTT462 300 mg QD n = 8	LTT462 400 mg QD n = 6	LTT462 450 mg QD n = 12	LTT462 600 mg QD n = 6	LTT462 150 mg BID n = 6	LTT462 200 mg BID n = 12
Value	0	0	16.7	0	0	0	16.7	33.3	16.7	33.3

Population analysed: The safety set included all participants who had received at least one dose of LTT462.

Primary outcome: Percentage of Participants With at Least One Dose Interruptions

Time frame: Up to 2.8 years. Number. Unit: Percentage of participants

Measure	LTT462 45 mg QD n = 2	LTT462 100 mg QD n = 3	LTT462 150 mg QD n = 6	LTT462 200 mg QD n = 4	LTT462 300 mg QD n = 8	LTT462 400 mg QD n = 6	LTT462 450 mg QD n = 12	LTT462 600 mg QD n = 6	LTT462 150 mg BID n = 6	LTT462 200 mg BID n = 12
Value	100	100	100	100	100	100	100	100	100	100

Population analysed: The safety set included all participants who had received at least one dose of LTT462.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were evaluated from screening until at least 30 days after the discontinuation of study treatment (Up to 2.8 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LTT462 45 mg QD	1 of 2 (50%)	2 of 2 (100%)	1 of 2
LTT462 100 mg QD	0 of 3 (0%)	3 of 3 (100%)	0 of 3
LTT462 150 mg QD	3 of 6 (50%)	6 of 6 (100%)	0 of 6
LTT462 200 mg QD	1 of 4 (25%)	4 of 4 (100%)	0 of 4
LTT462 300 mg QD	5 of 8 (62.5%)	8 of 8 (100%)	2 of 8
LTT462 400 mg QD	1 of 6 (16.7%)	6 of 6 (100%)	1 of 6
LTT462 450 mg QD	8 of 12 (66.7%)	12 of 12 (100%)	1 of 12
LTT462 600 mg QD	4 of 6 (66.7%)	5 of 6 (83.3%)	1 of 6
All QD Participants	23 of 47 (48.9%)	46 of 47 (97.9%)	6 of 47
LTT462 150 mg BID	3 of 6 (50%)	6 of 6 (100%)	1 of 6
LTT462 200 mg BID	5 of 12 (41.7%)	12 of 12 (100%)	0 of 12
All BID Participants	8 of 18 (44.4%)	18 of 18 (100%)	1 of 18

Limitations and caveats (from the sponsor): Following careful evaluation of the available study data and considering the limited clinical activity observed with LTT462, the decision was made to not open the dose expansion phase of the study and the study was terminated early.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

7 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LTT462 in people with Ovarian Neoplasms and Non-Small-Cell Lung Carcinoma, run by Novartis Pharmaceuticals at 7 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Germany, Japan, Singapore, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 2.8 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02711345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.